Dental CariesNCT03731780
Personalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults
A study testing Personalized Treatment and Chlorhexidine and Remineralization in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
Basic standard of care emphasis only tooth brushing and flossing without addressing individual pathological factors. For this reason, randomized controlled clinical trials on personalized caries management are needed to be able to compare the effectiveness of personalized caries management to basic standard of care. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Personalized Treatment and Chlorhexidine and Remineralization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2018to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- High caries risk patients
- 18-25 years
- Males or Females
- Patients approving to participate in the study -
Who cannot join
- Patients with systemic conditions
- Current periodontitis (sites of probing pocket depth ≥ 5 mm)
- Allergy to any of the ingredients of the study products
- Evidence of parafunctional habits
- Dysfunction of temporomandibular joint
- Use of antibiotics in the previous 30 days
Show all 10Show fewer
- Patients with developmental dental anomalies
- Patients with removable prosthesis
- Patients with Orthodontic appliance
- Periapical Abscess or Fistula and exposed pulps.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults: A Randomized Controlled Trial
Basic standard of care emphasis only tooth brushing and flossing without addressing individual pathological factors. For this reason, randomized controlled clinical trials on personalized caries management are needed to be able to compare the effectiveness of personalized caries management to basic standard of care. This is especially true in high caries risk populations and more so for young adults who stand to benefit the most from working towards a caries free adulthood.
Read the detailed description
Aim of the study: is to conduct an RCT to compare the effectiveness of a new personalized caries-control treatment protocol with standard caries treatment protocol for reducing caries incidence in high caries risk patients
Hypothesis: This project will be designed to test the null hypothesis that there is no significant difference between the new personalized caries-control treatment protocol and existing standard caries treatment protocol, and to test the alternative hypothesis that the new personalized treatment protocol will be superior to the standard preventive measures
Primary objective: is to measure the incidence of new caries lesions
- Conditions
- Dental Caries
- Being tested
- Personalized Treatment, Chlorhexidine and Remineralization, Control
- Keywords
- caries, prevention, personalized medicine
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized TreatmentOther
Targeting individual caries risk factors
Chlorhexidine and RemineralizationOther
chlorhexidine mouth wash and remineralizing agent
ControlOther
Control is standard preventive measures (tooth brushing, fluoride tooth paste, interdental cleaning)
| Study group | Role | What they receive |
|---|---|---|
| Personalized Treatment | Experimental | Intervention by (standard preventive measures + targeting individual caries risk factors) Receives: Other: Personalized Treatment |
| Chlorhexidine and Rremineralization | Experimental | Intervention is (chlorhexidine + Remineralizing agent + standard preventive measures) Receives: Other: Chlorhexidine and Remineralization |
| Control | Active comparator | standard preventative measures (tooth brushing, fluoride tooth paste, interdental cleaning) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of new caries lesions
incidence of new caries lesions
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study startDec 2018 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Khadr, Cairo University
- Investigators
- Fawzi, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731780
- Sponsor's protocol ID
- 2018cons1
- Status last verified
- Nov 2018
- First submitted
- 31 Oct 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available after publication upon request
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03731780
- Acronym / sponsor ID
- 2018cons1
- Conditions
- Dental Caries
- Keywords
- caries, prevention, personalized medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Basic standard of care emphasis only tooth brushing and flossing without addressing individual pathological factors. For this reason, randomized controlled clinical trials on personalized caries management are needed to be able to compare the effectiveness of personalized caries management to basic standard of care. This is especially true in high caries risk populations and more so for young adults who stand to benefit the most from working towards a caries free adulthood.
Detailed description
Aim of the study: is to conduct an RCT to compare the effectiveness of a new personalized caries-control treatment protocol with standard caries treatment protocol for reducing caries incidence in high caries risk patients
Hypothesis: This project will be designed to test the null hypothesis that there is no significant difference between the new personalized caries-control treatment protocol and existing standard caries treatment protocol, and to test the alternative hypothesis that the new personalized treatment protocol will be superior to the standard preventive measures
Primary objective: is to measure the incidence of new caries lesions
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized Treatment | Experimental | Other: Personalized TreatmentIntervention by (standard preventive measures + targeting individual caries risk factors) |
| Chlorhexidine and Rremineralization | Experimental | Other: Chlorhexidine and RemineralizationIntervention is (chlorhexidine + Remineralizing agent + standard preventive measures) |
| Control | Active comparator | Other: Controlstandard preventative measures (tooth brushing, fluoride tooth paste, interdental cleaning) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- High caries risk patients
- 18-25 years
- Males or Females
- Patients approving to participate in the study -
Key exclusion criteria (10 listed)
- Patients with systemic conditions
- Current periodontitis (sites of probing pocket depth ≥ 5 mm)
- Allergy to any of the ingredients of the study products
- Evidence of parafunctional habits
- Dysfunction of temporomandibular joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized TreatmentTargeting individual caries risk factors | Other | Personalized Treatment |
| Chlorhexidine and Remineralizationchlorhexidine mouth wash and remineralizing agent | Other | Chlorhexidine and Rremineralization |
| ControlControl is standard preventive measures (tooth brushing, fluoride tooth paste, interdental cleaning) | Other | Control |
Primary outcome
incidence of new caries lesions
Time frame: 12 month
incidence of new caries lesions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Individual participant dataSharing planned: Yes. Data will be made available after publication upon request
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fawzi, PhD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Treatment and Chlorhexidine and Remineralization in people with Dental Caries, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sherif khadr, Msc (+201007777939, sherifkhadr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of new caries lesions (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.